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Efficacy of Continuous Skin to Skin Care (Technique Kangaroo: TK) After Birth for Low Birth Weight (LBW) Infants and Their Mothers in Developing Countries (EtudeTK)

Primary Purpose

Low Birth Weight

Status
Completed
Phase
Not Applicable
Locations
Madagascar
Study Type
Interventional
Intervention
TK as soon as possible within 24 hours after birth
Conventional care
Sponsored by
Foundation for Advanced Studies on International Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Birth Weight focused on measuring Maternal and child health, Developing country, Skin to skin care, Newly born low birth weight infants and their mothers, (Delivery at University Hospital Center, Mahajanga, Madagascar)

Eligibility Criteria

undefined - 24 Hours (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Birth weight (BW) < 2500g
  • Delivery at maternity of CHUM (Birth < 24 hours)
  • Without serious congenital malformation
  • Sat O2 >=95％, HR > 100 / min, RR < 60 / min, Capillary refilling time < 3 sec
  • The mother and the family are motivated to practice TK.
  • The mother and the family available to practise TK should be healthy.

Exclusion Criteria:

  • Apnea of prematurity >20 sec
  • With intravenous infusion

Sites / Locations

  • University Hospital Center of Mahajanga (Centre Hospitalier Universitaire de Mahajanga: CHUM),

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

Mortality within 28 days after birth

Secondary Outcome Measures

Mobility within 28 days after birth
Mortality and Mobility within 28 days after birth
Difference of (Baby's) loss in weight within 2 days
Difference of (Baby's) Body weight of 14th day after birth
Difference of (Baby's) Body weight of 28th day after birth
Incidence of hypothermia during hospitalisation and (or) during outpatient department （lower than 35.5℃）
Incidence of bradycardia or tachycardia during hospitalisation (HR <100, or>180 /min)
Incidence of apnea during hospitalisation (> 20 sec)
Incidence of desaturation during hospitalisation ( <87%)
Length of hospitalisation
Discharge within 7days after birth
Mobility within 6 months or 1 year after birth
Mortality and Morbility within 6 months or 1 year after birth
Mortality within 6 months or 1 year after birth
Incidence of hyperthermia during hospitalisation and (or) outpatient department （upper than 37.5℃）

Full Information

First Posted
September 17, 2007
Last Updated
December 8, 2011
Sponsor
Foundation for Advanced Studies on International Development
Collaborators
St.Luke's Life Science Institute, Tokyo, Japan
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1. Study Identification

Unique Protocol Identification Number
NCT00531492
Brief Title
Efficacy of Continuous Skin to Skin Care (Technique Kangaroo: TK) After Birth for Low Birth Weight (LBW) Infants and Their Mothers in Developing Countries
Acronym
EtudeTK
Official Title
Randomized Controlled Trial of Continuous Skin to Skin Care (Technique Kangourou: TK) for Low Birth Weight (LBW) Infants and Their Mothers at University Hospital Center of Mahajanga (Centre Hospitalier Universitaire de Mahajanga: CHUM), Madagascar
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Foundation for Advanced Studies on International Development
Collaborators
St.Luke's Life Science Institute, Tokyo, Japan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to examine the efficacy of Technique Kangourou (TK) between low birth weight (LBW) infants and their mothers started as soon as possible within 24 hours after birth in developing country. For the purpose of this study, TK is defined as skin-to-skin direct and continuous (24 hours) contact between LBW infants and their mothers or any other people who substitute mothers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Birth Weight
Keywords
Maternal and child health, Developing country, Skin to skin care, Newly born low birth weight infants and their mothers, (Delivery at University Hospital Center, Mahajanga, Madagascar)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
TK as soon as possible within 24 hours after birth
Intervention Description
Start TK as soon as possible within 24 hours after birth
Intervention Type
Other
Intervention Name(s)
Conventional care
Intervention Description
Start conventional care (At first use incubator, and start TK when the infants and mother are completely settled and ready)
Primary Outcome Measure Information:
Title
Mortality within 28 days after birth
Time Frame
within 28 days after birth
Secondary Outcome Measure Information:
Title
Mobility within 28 days after birth
Time Frame
within 28 days after birth
Title
Mortality and Mobility within 28 days after birth
Time Frame
within 28 days after birth
Title
Difference of (Baby's) loss in weight within 2 days
Time Frame
within 2 days
Title
Difference of (Baby's) Body weight of 14th day after birth
Time Frame
14th day after birth
Title
Difference of (Baby's) Body weight of 28th day after birth
Time Frame
28th day after birth
Title
Incidence of hypothermia during hospitalisation and (or) during outpatient department （lower than 35.5℃）
Time Frame
Within 28 days after birth
Title
Incidence of bradycardia or tachycardia during hospitalisation (HR <100, or>180 /min)
Time Frame
within 28 days after birth
Title
Incidence of apnea during hospitalisation (> 20 sec)
Time Frame
within 28 days after birth
Title
Incidence of desaturation during hospitalisation ( <87%)
Time Frame
within 28 days after birth
Title
Length of hospitalisation
Time Frame
within 28 days after birth
Title
Discharge within 7days after birth
Time Frame
within 7days after birth
Title
Mobility within 6 months or 1 year after birth
Time Frame
within 6 months or 1 year
Title
Mortality and Morbility within 6 months or 1 year after birth
Time Frame
within 6 months or 1 year
Title
Mortality within 6 months or 1 year after birth
Time Frame
within 6 months or 1 year
Title
Incidence of hyperthermia during hospitalisation and (or) outpatient department （upper than 37.5℃）
Time Frame
Within 28 days after birth

10. Eligibility

Sex
All
Maximum Age & Unit of Time
24 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Birth weight (BW) < 2500g Delivery at maternity of CHUM (Birth < 24 hours) Without serious congenital malformation Sat O2 >=95％, HR > 100 / min, RR < 60 / min, Capillary refilling time < 3 sec The mother and the family are motivated to practice TK. The mother and the family available to practise TK should be healthy. Exclusion Criteria: Apnea of prematurity >20 sec With intravenous infusion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuko Nagai, MD
Organizational Affiliation
Groupe d'Etude de la Technique Kangourouà Mahajanga, Madagascar
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Center of Mahajanga (Centre Hospitalier Universitaire de Mahajanga: CHUM),
City
Mahajanga
Country
Madagascar

12. IPD Sharing Statement

Citations:
PubMed Identifier
20121708
Citation
Nagai S, Andrianarimanana D, Rabesandratana N, Yonemoto N, Nakayama T, Mori R. Earlier versus later continuous Kangaroo Mother Care (KMC) for stable low-birth-weight infants: a randomized controlled trial. Acta Paediatr. 2010 Jun;99(6):827-35. doi: 10.1111/j.1651-2227.2009.01676.x. Epub 2010 Jan 27.
Results Reference
result
PubMed Identifier
21635363
Citation
Nagai S, Yonemoto N, Rabesandratana N, Andrianarimanana D, Nakayama T, Mori R. Long-term effects of earlier initiated continuous Kangaroo Mother Care (KMC) for low-birth-weight (LBW) infants in Madagascar. Acta Paediatr. 2011 Dec;100(12):e241-7. doi: 10.1111/j.1651-2227.2011.02372.x. Epub 2011 Jun 23.
Results Reference
result

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Efficacy of Continuous Skin to Skin Care (Technique Kangaroo: TK) After Birth for Low Birth Weight (LBW) Infants and Their Mothers in Developing Countries

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